Boluses of Ringer's in Surgical Kids (BRiSK Study)

Children's Hospital of Philadelphia (CHOP)

Status and phase: Completed; Early Phase 1

Conditions: Fluid Therapy; Dehydration in Children

Treatments: Other: Medical Chart Review; Diagnostic Test: Complete Metabolic Panel (CMP); Diagnostic Test: Urinalysis (UA); Diagnostic Test: Glucose Stick Test (d-Stick)

Study type: Interventional

Funder types: Other

Identifiers

NCT05285371

21-019180

Details and patient eligibility

About

Traditional protocols for intravenous fluid administration in children who have undergone a major abdominal or thoracic operation are based on a landmark paper published in 1957 by Holliday and Segar. The basic tenets include: (1) Continuous intravenous fluid administration; (2) Total fluid volume based on the "4:2:1" rule; (3) Use of hypotonic electrolyte solutions, most commonly 0.45% sodium chloride (NaCl) + 20 milliequivalents per liter (mEq/L) potassium chloride (KCl); and (4) Inclusion of 5% dextrose to increase the osmolarity of the infusate and to help prevent ketosis and acidemia.

Full description

Recent studies have questioned the validity of each of these tenets. Maintenance rate as defined by Holliday & Segar is postulated to be in excess of pediatric patients' post-surgical fluid needs. The investigators propose a novel protocol for the administration of IV fluids to children after major abdominal or thoracic surgery that includes: (1) Intermittent boluses; (2) Total volume administered in 24 hours closer to 2/3 of the traditional maintenance fluid requirements; and (3) Use of a balanced salt solution (Lactated Ringer).

Enrollment: 70 patients

Sex: All

Ages: 1 to 21 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Males or females age 12 months to 21 years.
2. Weight >= 8 kg.
3. Patients with an uncomplicated abdominal or thoracic surgical procedure in which the expected postoperative length of stay is anticipated to be at least 2-5 days.
4. Patients admitted to a regular bed following surgery.
5. Patients who will be inpatient for approximately 4-8 days postoperatively.
6. Parental/guardian permission (informed consent).

Exclusion criteria

1. Patients with a history of diabetes, seizures, hyperglycemia, and hypoglycemia.

2. Patients prescribed insulin.

3. Patients receiving parenteral nutrition.

4. Patients with excessive GI losses (small bowel obstruction, severe diarrhea, large-volume ascites or drainage).

5. Complicated surgery that requires an ICU or ICU transfer immediately after surgery.

6. Patients with any form of hypersensitivity to the study fluids.

7. Laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary, or renal disease:

   • Serum Sodium <130 or >145 mmol/L
   • Serum Potassium <3.0 or >5.0 mEq/L
   • Serum Chloride <90 or >110 mEq/L
   • Serum Creatinine ≥ 1.6 mg/dL
   • Serum Glucose <60 or >180 mg/dL
   • Alanine Aminotransferase >200 U/L
   • Total Bilirubin >12.0 mg/dL

8. Pregnant or lactating females.

9. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

70 participants in 2 patient groups, including a placebo group

CONT Group

Placebo Comparator group

Description:

CONT group will receive standard traditional intravenous fluid of D50.45% NaCl + 20 mEq/L KCl at 2/3 maintenance rate.

Treatment:

Diagnostic Test: Glucose Stick Test (d-Stick)

Diagnostic Test: Urinalysis (UA)

Other: Medical Chart Review

Diagnostic Test: Complete Metabolic Panel (CMP)

BOL Group

Experimental group

Description:

BOL group will receive intravenous boluses of Lactated Ringer's three times daily at 2/3 maintenance rate.

Treatment:

Diagnostic Test: Glucose Stick Test (d-Stick)

Diagnostic Test: Urinalysis (UA)

Other: Medical Chart Review

Diagnostic Test: Complete Metabolic Panel (CMP)